Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000549628
Ethics application status
Approved
Date submitted
12/05/2023
Date registered
23/05/2023
Date last updated
22/07/2024
Date data sharing statement initially provided
23/05/2023
Date results provided
22/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Eat, Sleep, Play- CP: Investigating nutrition and body composition in children with cerebral palsy
Scientific title
Eat, Sleep, Play: Investigating nutrition and body composition in children with Hokai Nukurangi - cerebral palsy: A feasibility study
Secondary ID [1] 309655 0
None
Universal Trial Number (UTN)
Trial acronym
Eat, Sleep, Play- CP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebral palsy 329993 0
Condition category
Condition code
Diet and Nutrition 326901 326901 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a feasibility study for our 'Eat, Sleep, Play-CP' intervention.

The focus of the intervention primarily focuses on the child’s energy and protein intake, with the additional scope of the timing of protein intake in relation to the child’s activity patterns.
The nutritional information provided for the intervention has been developed based on the Nutrient Reference Values for Australia and New Zealand Including Recommended Dietary Intake (NHMRC Ministry of Health and adaptations from The American College of Sports Medicine Joint position statement: Nutrition and Athletic performance.
The “Sleep” and “Play” components are developed from the “24 hour Activity Clinical practice guide” for children with CP.
At T1, parent/caregiver and child will receive their “Eat, Sleep, Play” Profile, which will appear somewhat like a report card centred on 3 key areas.
- Total energy intake: The NRV will be used which will be relevant to the age and physical activity level of the child
- Total protein intake: As per the NR
- Protein intake after physical activity: recommended as ~10% daily recommendation

Total energy; if a participant is found to be consuming above the recommended energy intake, advice will be provided around how to decrease this. This advice will be personalised to the dietary intake of the individual and may include advice around a decrease in intake of high fat, sugar and salt foods for example chocolate, confectionary, potato chips, chocolate or cream-filled biscuits, fast food and sugary drinks. If a participant is found to be consuming below the recommended energy intake, advice will be provided on how to increase this. This will be personalised and may include advice around the increase of foods such as fruit, yoghurt, vegetable sticks with a low-fat dip (eg, hummus or yoghurt-based dips), mini-sandwiches, nuts and seeds, fresh fruit smoothie, plain popcorn, and unsweetened breakfast cereal with milk.

Total protein: if a participant is found to be consuming below the recommended protein intake, personalised advice will be provide to increase their protein intake through an increase in food sources of protein which are meat, poultry, fish, milk, milk products, eggs, legumes, tofu, nuts and seeds.

Protein after activity: If a participant is found not to consume adequate protein after activity, personalised advice will be provided and suggestions of protein rich foods will be given. Food sources of protein include meat, poultry, fish, milk, milk products, eggs, legumes, tofu, nuts and seeds.

One Masters of Dietetics student will deliver the "intervention", which includes a ~30minute discussion about their current dietary intake, goal setting on where they can improve on their intake, and co-developed strategies on how this can be achieved. This discussion will primarily take place in person, however if the participant prefers (i.e due to time limitations or if the chlilds is tired) and/or if schedulling issues occur, the discussion will take place via videconfernce (the mode of the delivery will be recorded). The discussion points raised with the child/family will have been previously discussed with a NZ Registered Paediatric Dietitian and adjusted as needed. A checklist (developed for the study) will help guide the students’ discussion, and families will be provided with: their profile, a written summary of their goals and strategies, and an information pack to refer to over the following 12 weeks. The information pack has been developed for the study,

Participants will receive up to four phone call/email/text check in (to the preference of the participant) to see how they are managing, and to provide advice and tips on how to follow the recommendations as needed. This will be spaced as follows: week 2, week 4, week 7, week 10, with the length of time varying depending on the families needs. It is anticiapted that this will be less than 10 minutes.
Intervention code [1] 326124 0
Treatment: Other
Comparator / control treatment
No control
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334740 0
Total energy intake, collected via an online food recall tool called Intake24. This is a 24hour dietary that the parent/caregiver will complete on behalf of/with the help of the child over three days.

Rowland MK, Adamson AJ, Poliakov I, Bradley J, Simpson E, Olivier P, et al. Field Testing of the Use of Intake24—An Online 24-Hour Dietary Recall System. Nutrients. 2018;10(11):1690.
Timepoint [1] 334740 0
T2 (12 weeks after initial discussion)
Primary outcome [2] 334786 0
Total protein intake, collected via an online food recall tool called Intake24. This is a 24hour dietary that the parent/caregiver will complete on behalf of/with the help of the child over three days.
Timepoint [2] 334786 0
T2 (12 weeks after initial discussion)
Primary outcome [3] 334787 0
Timing of protein intake, collected with infromation taken food recall diary, with the timing of protein intake matached to a set of questions (administed via qualtrics) that asks the family when the child was 'most active' throughough the days that they completed the food recall diary.
Timepoint [3] 334787 0
T2 (12 weeks after initial discussion)
Secondary outcome [1] 421915 0
Fat mass %, as captured via DXA scan
Timepoint [1] 421915 0
T2 (12 weeks after initial discussion)
Secondary outcome [2] 422094 0
Fat free mass %, as captured via DXA scan
Timepoint [2] 422094 0
T2 (12 weeks after initial discussion)
Secondary outcome [3] 422095 0
Bone mineral density, as captured via DXA scan
Timepoint [3] 422095 0
T2 (12 weeks after initial discussion)

Eligibility
Key inclusion criteria
i) Children with a confirmed diagnosis of CP aged 5-12 years.
ii) All EDACS and GMFCS levels.
iii) Living within the Auckland metropolitan region and/or able to travel to the University of Auckland, Grafton on two occasions.
iv) At least one parent/caregiver understands written and verbal English and can speak English.
v) Access to a phone/tablet and/or internet
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) Dyskinesia preventing the ability to lie still for 10 minutes.
ii) Inability to transfer from chair to bed (~60 cm high) without requiring a hoist.
iii) Any implants, hardware, devices, or other foreign implanted material that may interfere with body composition assessment
iv) Current, recent (3 months prior) or planned feeding tube (a percutaneous endoscopic gastrostomy (PEG), or similar) inserted through the study period.
v) Under any specific clinical dietary guidance or textured modified foods and/or fluids
vi) Uncontrolled epilepsy.
vii) Planned orthopaedic surgery 6 months prior to or throughout the study period.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As a feasibility study, no power calculation has been used to determine sample size of phase two,. A target sample size of 10-15 is based on recommendations, and the projected study timeline for the Masters’ students completing this project.

Planned analysis
Objective 1: Describe the dietary intake of children with CP, and to scope the extent of any dietary advice received by families of children with CP living in New Zealand.
Planned analysis: A descriptive analysis of grouped participant data (median and range) scores for dietary intake will be undertaken. Sub-group descriptive analysis (i.e. presenting data within participant groupings by GMFCS level or EDACS level) may be presented if appropriate sample sizes are achieved.
The proportion of participants reporting that they had received prior dietary advice will be calculated, and any free-text responses will be summarised qualitatively.

Objective 2: Determine the relationship between variables of dietary intake with body composition (Fat mass %, lean body mass %, Bone Mineral Density) in children with CP.
Planned analysis: The relationship between variables of dietary intake and body composition will be determined via Pearson or Spearman correlation analysis, for normally and non-normally distributed data, respectively. If appropriate, a multivariable regression analysis will be used to assess the relationship between dietary intake and body composition, adjusting for GMFCS level. A p-value of <0.05 will be used to determine statistically significance.

Objective 3: Evaluate the feasibility of an individualised dietary intervention for supporting improved body composition over a 12-week period.
Feasibility will be assessed by:
- Acceptability (recruitment rates, completion of assessments, and participant satisfaction with the intervention (Likert scale satisfaction, free text responses),
- Efficacy testing (change in outcomes following intervention).

Planned analysis:
- The Acceptability of the study and intervention will be estimated through recruitment rates (i.e. number of participants recruited over the set study period), completion rates of assessments (questionnaires, 24 hour dietary recalls, and DXA scans), and participant satisfaction with the intervention (Likert scale responses to Questions within Block 2).
- The potential efficacy of the developed intervention upon key variables of dietary intake and body composition (fat mass %, lean mass % and BMD), will be estimated through measurement of changes in outcomes before and after the intervention period (T2-T1).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/06/2023
Actual
20/06/2023
Date of last participant enrolment
Anticipated
31/08/2023
Actual
7/08/2023
Date of last data collection
Anticipated
15/12/2023
Actual
22/11/2023
Sample size
Target
10
Accrual to date
Final
9
Recruitment outside Australia
Country [1] 25501 0
New Zealand
State/province [1] 25501 0
Auckland region

Funding & Sponsors
Funding source category [1] 313845 0
University
Name [1] 313845 0
Univerisity of Auckland- Staff research development funds
Country [1] 313845 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Liggins institute, University of Auckland
85 Park rd, Grafton
Auckland, New Zealand
1023
Country
New Zealand
Secondary sponsor category [1] 315675 0
None
Name [1] 315675 0
Address [1] 315675 0
Country [1] 315675 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312995 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 312995 0
Ethics committee country [1] 312995 0
New Zealand
Date submitted for ethics approval [1] 312995 0
09/03/2023
Approval date [1] 312995 0
11/05/2023
Ethics approval number [1] 312995 0
2023 FULL 15406

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126622 0
Dr Sian Williams
Address 126622 0
Curtin University, GPO Box U1987 Perth, Western Australia 6845.
Country 126622 0
Australia
Phone 126622 0
+61 0892663645
Fax 126622 0
Email 126622 0
[email protected]
Contact person for public queries
Name 126623 0
Sian Williams
Address 126623 0
Curtin University, GPO Box U1987 Perth, Western Australia 6845.
Country 126623 0
Australia
Phone 126623 0
+61 0892663645
Fax 126623 0
Email 126623 0
[email protected]
Contact person for scientific queries
Name 126624 0
Sian Williams
Address 126624 0
Curtin University, GPO Box U1987 Perth, Western Australia 6845.
Country 126624 0
Australia
Phone 126624 0
+61 0892663645
Fax 126624 0
Email 126624 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Given our small participant cohort we are mindful or protecting our particpants identity.Grouped data may be made available upon reasonable request


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.